Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed unresectable stage III or IV melanoma from a cutaneous, mucosal, or unknown primary site

  • Unresectable stage III disease, defined as meeting 1 of the following criteria:

    • Regional metastasis that, in the judgement of the treating physician, cannot be surgically resected with clear margins
    • Regional metastasis that can be surgically resected with clear margins only by extensive surgery that is inadvisable or unacceptable to the treating physician and/or patient
  • Staging of cutaneous and mucosal melanoma based on the revised American Joint Committee on Cancer (AJCC) staging system
• Must have measurable disease as defined by Response Evaluation Criteria in Small Tumors (RECIST) criteria
• No ocular melanoma

• Patients with brain metastases may be eligible if all of the following are true:

  • Total number of brain metastases ever is ≤ 3

  • Each brain metastasis has been completely removed by surgery or each unresected brain metastasis has been treated with stereotactic radiosurgery

    • Stereotactic radiosurgery, such as gamma knife, can be used up to 1 week before study entry
    • No evident growth of any brain metastasis since treatment
  • No brain metastasis that is > 2 cm in diameter at study entry

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 9 g/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin normal
• Creatinine ≤ 1.5 times ULN
• No New York Heart Association class III or IV heart disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No previous or concurrent autoimmune disorder requiring cytotoxic or immunosuppressive therapy

• No autoimmune disorder with visceral involvement

  • The following conditions are allowed:

    • Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
    • Clinical evidence of vitiligo
    • Other forms of depigmenting illness
    • Mild arthritis requiring steroidal anti-inflammatory drugs
• HIV negative
• Hepatitis C negative
• No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy

PRIOR CONCURRENT THERAPY:

• No more than 1 previous chemotherapy regimen for metastatic melanoma
• No previous paclitaxel
• No chemotherapy, interferon, growth factors, interleukin, or radiotherapy (excluding gamma knife therapy for brain metastases) within the past 4 weeks
• No surgical resection of metastatic lesions within the past 4 weeks
• No other investigational medication within the past 4 weeks or during study
• No nitrosoureas (e.g., carmustine or lomustine) within the past 6 weeks and during study treatment
• No other concurrent chemotherapy, interferon, other growth factors, interleukin, illegal drugs, radiotherapy, surgery, or steroid therapy
• No concurrent oral or injectable hydrocortisone (at doses > 15 mg per day) or its equivalent